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Intensive Accelerated iTBS for the Treatment-Resistant Depression
Sponsor: Changping Laboratory
Summary
This study is a multicenter, randomized, double-blind, and sham-controlled trial using most intensive aiTBS protocol (10 sessions daily over 5 consecutive days at triple the standard per-session dose) to investigate the antidepressant efficacy for treatment-resistant depression (TRD). Patients will be recruited and randomly assigned (1:1 ratio) to receive active or sham groups from 5 hospitals in China. The interventions will last for 5 days and both groups will be followed up for 8 weeks on the same time schedules. During the intervention and at least the first 4 weeks of post-treatment, participants will keep a stable antidepressant regimen. The individualized target in the left dorsolateral prefrontal cortex (DLPFC) will be generated from 30 minutes of resting-state functional MRI collected at baseline.
Official title: Intensive Accelerated Intermittent Theta Burst Stimulation in Treatment-resistant Depression: A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Trial
Key Details
Gender
All
Age Range
22 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2023-12-22
Completion Date
2025-04-21
Last Updated
2026-05-11
Healthy Volunteers
No
Conditions
Interventions
Active iTBS-DLPFC
Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days.
Sham iTBS-DLPFC
The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.
Locations (5)
Hebei Mental Health Center
Baoding, China
HuiLongGuan Hospital
Beijing, China
Wuhan Mental Health Center
Wuhan, China
Xianyue Hospital
Xiamen, China
Zhumadian Second People's Hospital
Zhumadian, China